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UNIVERSITY OF ILLINOIS HOSPITAL 1740 WEST TAYLOR ST SUITE 1400 CHICAGO, IL 60612 Aug. 7, 2014
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


A. Based on document review and interview, it was determined, for 1 of 1 clinical record review (Pt. #1) for a patient with court ordered psychotropic medications, the hospital failed to ensure patients were informed if/when medication was administered in food.

Findings include:

1. On 8/6/13 at 10:00 AM, Hospital policy titled, "Patient's Rights and Responsibilities", approved/effective on 10/16/13, was reviewed. The policy required, "As our patient, you have the right to information about your treatment... To be involved in decision making regarding your plan of care..."

2. Beginning on 8/6/14 at 9:00 AM through 8/7/14 at 2:00 PM, Pt. #1's clinical record was reviewed. Pt. #1 was a [AGE] year old male, admitted on [DATE], with a diagnosis of Bipolar Associated Disorder vs. Psychosis NOS [Not Otherwise Specified].

3. On 10/15/13, a court order (State of Illinois Circuit Court for the First Judicial Circuit Cook County docket no. 2013 COMH 3) was issued to involuntarily administer psychotropic medications to Pt. #1. Nineteen medications were included in the order, including Risperidone and Divalproex Sodium (Depakote). Risperidone is used to treat schizophrenia and Depakote is prescribed for bipolar mania. The order included, "Risperidone regular or orally disintegrating tablet 2 mg - 8 mg PO [by mouth] per day" and "Divalproex Sodium 500 - 3500 mg PO per day".

4. A Psychiatric Resident's (MD #1) order on 10/24/13 at 4:00 PM, included, " Divalproex Sodium, 500 mg, PO, AC [before meal] dinner, routine, first dose 10/24/13 4:00 PM, do not crush. Please open capsule and add to soft food is court-mandated medication " .

5. Pt. #1's medication administration record (MAR) included documentation on 10/24/13, Divalproex Sodium, 500 mg, was administered PO at 4:00 PM and Risperidone, 1 mg, PO at 5:00 PM.

6. The Hospital provided a manufacturer's (Mylan Pharmaceuticals) insert which was reviewed on 8/7/14 at 3:00 PM. The insert included, "Swallow Divalproex sodium extended-release tablets. Tell your healthcare provider if you can not swallow Divalproex sodium extended-release tablets whole. You may need a different medicine." This insert did not include sprinkling the tablet contents into food.

7. WebMD.com was reviewed on 8/7/14 and included information regarding "How to use Depakote Sprinkles oral - Take this medication by mouth as directed by your doctor. You may take it with food if stomach upset occurs. This medication may be swallowed whole or the capsule can be opened and the entire contents sprinkled onto a small amount (teaspoonful) of soft food, such as applesauce or pudding..."

8. A nursing note (E #6) dated 10/24/13 at 5:52 PM, included, "Patient paranoid about medications. Patient stated 'I won't take any medications by mouth and when I get out of here I won't take any meds at all... out for meals only... Depakote mixed with his soup. Patient ate whole cup of soup. Risperidone mixed with juice, offered to patient and patient drunk the juice..." E #6 failed to inform Pt. #1, medication was in his food.

9. Rxlist.com was reviewed on 8/7/14 and included information regarding, "You may open the Divalproex sodium sprinkle capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow this mixture right away. Do not crush, chew, break, or open a delayed-release or extended-release tablet or capsule. Swallow it whole... Store at room temperature away from moisture and heat." These instructions did not include if the medication could be added to soup, which could not be consumed "right away" or if heat in the soup would change the medication's constitution.

10. On 8/7/14 at 1:25 PM, an interview was conducted with E #6, who administered Pt. #1's PO medication in food on 10/24/13 at dinner. E #6 stated Pt. #1 liked soup and was asked if the medication could be added. Pt. #1 agreed and drank the soup. E #6 stated Pt. #1 ate in his room and was aware he was taking PO medications. E #6's verbal account contradicted his written documentation.

11. MD #1 progress note dated 10/25/13 at 8:05 AM included, "Per nursing notes, took one dose of Depakote 500 mg when provided in sprinkle formulation. Unfortunately, he then refused further doses of medication once he observed its administration.

12. Pt. #1's discharge summary dated 11/19/13 at 8:32 AM, included, "...On 10/24/13, patient took all oral medication when provided in alternative formulation. Depakote sprinkles and Risperidone were added to food since court-ordered medication with court providing consent with goal of quickly treating mania... Food adulteration was discontinued once patient began refusing food observing medication being added to tray..."

B. Based on document review and interview, it was determined, for 1 of 1 clinical record review (Pt. #1) for a patient with court ordered psychotropic medications, the hospital failed to ensure court ordered medication were administered as ordered.

Findings include:

1. On 10/15/13, a court order (State of Illinois Circuit Court for the First Judicial Circuit Cook County docket no. 2013 COMH 3) was issued to involuntarily administer psychotropic medications to Pt. #1. Nineteen medications were included in the order, including Risperidone and Divalproex Sodium (Depakote). Risperidone is used to treat schizophrenia and Depakote is prescribed for bipolar mania. The order included, "Risperidone regular or orally disintegrating tablet 2 mg - 8 mg PO [by mouth] per day" and "Divalproex Sodium 500 - 3500 mg PO per day". The order did not include intravenous (IV) administration of Risperidone or Depakote.

2. Beginning on 8/6/14 at 9:00 AM through 8/7/14 at 2:00 PM, Pt. #1's clinical record was reviewed. Pt. #1 was a [AGE] year old male, admitted on [DATE], with a diagnosis of Bipolar Associated Disorder vs. Psychosis NOS [Not Otherwise Specified].

3. On 10/29/13 at 9:00 AM, a Psychiatric Resident (MD #1) ordered, "Valproic acid [Depakote], 500 mg, injection, IVPB [intravenous piggy back], daily, routine, first dose 10/29/13 9:00 AM. Court ordered medication, if oral Depakote is refused, please provide IV Valproic acid in its place."

4. Pt. #1's medication administration record (MAR) included Valproic acid (Depakote) were administered at 9:00 AM daily as IVPB from 10/29/13 through 11/11/13.
Pt. #1's court order included PO as the only route of administration for Depakote, whereas Pt. #1 received Depakote via IVPB.

5. An interview was conducted with Pt.#1's Attending Physician (MD #1) on 8/6/14 at 11:25 AM. MD #1 stated all the medication Pt. #1 received was approved by the judge and is in the court paperwork. Pt. #1 may have received Depakote IV for agitation. MD #1 did not provide court document that included administration of Depakote IV administration.






C. Based on document review and interview, it was determined for 5 of 5 (Pt's. # 1-5) patients with psychotropic medications ordered, the hospital failed to ensure documentation of each patient's informed consent including medication education was completed.

Findings include:

1. Hospital policy titled, "Medication Education (reviewed November '13)", reviewed 8/7/14, required, "Prior to prescribing psychotropic medication, the physician will inform the patient of the medication proposed to be administered, the clinical indication for the medication, as well as the risk and benefits, common side effects, and alternative treatment... This discussion will be documented..."

2. The clinical records of Pt's. # 1-5 were reviewed on 8/6/14.

- Pt. #1 was a [AGE] year old male, admitted on [DATE], with a diagnosis of Bipolar Associated Disorder vs. Psychosis NOS [Not Otherwise Specified]. The clinical records lacked documentation of patient education and consent for medication usage

- Pt. #2 was a [AGE] year old female, admitted on [DATE], with a diagnosis of Autism Spectrum Disorder. The clinical records lacked documentation of patient education and consent for medication usage

- Pt. #3 was a [AGE] year old male, admitted on [DATE], with diagnoses of Autism and Mild Mental Retardation. The clinical records lacked documentation of patient education and consent for medication usage

- Pt. #4 was a [AGE] year old male, admitted on [DATE], with a diagnosis of Autism. The clinical records lacked documentation of patient education and consent for medication usage

- Pt. #5 was a [AGE] year old male, admitted on [DATE], with a diagnosis of Schizoaffective Bipolar Disorder. The clinical records lacked documentation of patient education and consent for medication usage

3. During an interview on 8/7/14 at approximately 10:30 AM, the Clinical Nurse Specialist (E#5) stated the medication information should be documented in the physician inpatient assessment. E#5 was unable to locate the documentation in the clinical records.